FDA approves sale of Bose over-the-counter hearing device

The Food and Drug Administration (FDA) has authorized Bose to sell a hearing aid that can be used without the assistance of a health professional. Hearing aids are not new, but it is the first model that will allow users to "adapt, program, and control hearing aids themselves without the help of a health care provider." .

The FDA report states that more than 37 million Americans suffer from hearing loss whose severity can range from a "small problem" to "a deaf person". Hearing can be impaired due to a number of factors, including aging, exposure to extremely loud noises, or certain medical conditions. The Bose device is intended for people with mild to moderate hearing loss.

One of the advantages of the Bose device is that it can be controlled and programmed via a mobile application, allowing users to make the necessary adjustments according to their needs. The device itself is an air conduction hearing aid that captures sound waves and amplifies them with the help of microphones to produce louder sounds.

Malvina Eydelman, Director of the Division of Ophthalmologists and Hearing, Nasal and Nasal Devices at the Radiology and Radiation Health Equipment Center of the FDA, said the approval of the Bose device should allow patients with disorders Light to moderate hearing aids easily obtain the help they need.

"Today's marketing authorization allows some patients to have access to a new hearing aid that allows them to directly control the fit and functionality of their device," said Eydelman. "The FDA is committed to ensuring that people with hearing loss have the opportunity to play an active role in their health care."

Although this device is the first of its kind to be approved for commercialization, it will not be the last. In 2017, Congress passed legislation allowing the sale of over-the-counter hearing aids, which means we will see many similar products on the market in the months and years to come. However, these devices will still need to comply with local and national laws, which may require a visit to a health care professional to obtain a hearing aid.

It's Bose's first over-the-counter hearing instrument, but it's not the first time they've made a product that can help people in communication. In 2016, the company announced a set of headphones likely to enhance conversations, thus making it easier to listen to people in noisy places such as crowded bars or restaurants.